
Most people assume that if there is a problem with drug quality, it must be a manufacturing issue, a company issue, or a regulatory oversight issue. Recently, I watched a clip from a Senate hearing on the quality of generic drugs (link), and the discussion gave the impression that lawmakers had “just” discovered an anomaly that needed to be investigated and fixed. But this is not an anomaly. This is not new. This is the predictable result of a system that replaced real science with rituals, regulations, and the illusion of science.
Drug products are not medical concepts. They are chemical products. Their identity, purity, strength, stability, and quality are chemical properties. Therefore, drug quality is a chemistry problem. Medicine is about diagnosing illness and prescribing drugs, not about defining chemical quality, developing analytical methods, or setting manufacturing standards. Those are scientific responsibilities, not medical ones.
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